Identity
- Device Name
- Reagents for Urine Analyzer EUDAMED
- Model / Reference
- URS-403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974410140080 EUDAMED
- Basic UDI-DI
- 697441014RUA0004HR EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Reagents for Urine Analyzer by Bioway Biological Technology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697441014RUA0004HR | Class A | Active |
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Manufacturer
- Manufacturer
- Bioway Biological Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000026464
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED c7d38aec-93f7-41a1-9dc2-7032b6116dd7 61 fields · synced Jun 18, 2026